Fas inhibitor shows benefit in some cases of macula-off rhegmatogenous retinal detachment
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CHICAGO — A Fas inhibitor showed strong efficacy signals and demonstrated in patients with more than 8 days of macula-off rhegmatogenous retinal detachment, according to a study.
In a presentation at Retina Subspecialty Day at the American Academy of Ophthalmology meeting, Durga S. Borkar, MD, MMCi, said that patients with macula-off rhegmatogenous retinal detachment (RRD) can experience vision loss even after surgical repair.
“Many studies have shown that time is vision when it comes to the duration of macula-off status,” she said. “The Scottish Retinal Detachment Study, among others, showed that the extent of vision loss increases with the duration of macula-off status, especially if the macula is detached for greater than 8 days.”
A phase 2 study assessed the safety and efficacy of intravitreal ONL1204 (ONL Therapeutics), a Fas inhibitor, in patients with macula-off RRD; 135 patients were randomly assigned to receive 50 µg or 200 µg of ONL1204 or sham at least 12 hours prior to and no more than 10 days before surgery.
The study’s primary efficacy endpoint was contrast sensitivity measured by the Manifold contrast vision meter (Adaptive Sensory Technology) at week 24. Best corrected visual acuity, reading speed and other secondary endpoints were also assessed at week 24.
Borkar said there was no significant difference across the treatment groups in terms of contrast sensitivity. However, an analysis of prespecified subgroups demonstrated a trend toward neuroprotection in patients with more than 8 days of macula-off status.
Additionally, patients with more than 8 days of macular detachment experienced an approximately two line better improvement in BCVA in the 200 µg group compared with sham.
“ONL1204 was safe and well tolerated with strong efficacy signals with one injection at the time of diagnosis and a demonstrated trend toward neuroprotection in patients with greater than 8 days of macula-off status,” Borkar said. “Further research will look at these patients at highest risk of vision loss.”